|Medtronic's Advisa is the first MRI-friendly pacemaker available in Japan--courtesy of Medtronic|
Medtronic ($MDT) is launching its MRI-safe Advisa pacemaker in Japan, the first such device available in the country.
Japan's 400,000 pacemaker users are contraindicated for MRI scans, Medtronic says, and the company estimates that between 50% and 75% of pacemaker users eventually need the procedure. That means a huge unmet need in the world's second-largest medical device market, the company figures.
Advisa is still in the midst of an IDE study for FDA approval in the states, but Medtronic got 510(k) clearance last year for Revo, an earlier-generation pacer deemed MRI-safe. St. Jude Medical ($STJ) and Boston Scientific ($BSX) have scan-ready pacemakers on the market around the world, and St. Jude is running trials to get FDA approval for its Accent MRI pacer.
Of course, all the angling to get MRI-safe devices into the hands and hearts of patients assumes pacemakers really are incompatible with scans. A recent study in the American Journal of Cardiology examined the records of 109 patients with pacers and ICDs who received MRIs, finding that all of them came out with devices intact and no heart rhythm disruption.
Then again, it's just one study, but if further research motivates regulators and physicians to pivot on the issue, that sizable unmet need cited by Medtronic and its competitors might just disappear.
- read Medtronic's release